原创力文档美国FDA 法规 指南- 决定何时提交510(k)变更现有器械(K97-1) Guidance-Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1).pdfVIP
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Deciding When to Submit a 510(k)
for a Change to an Existing Device
This document is intended to provide guidance in the
preparation of a regulatory submission. It does not bind the
FDA or the regulated industry in any manner.
Office of Device Evaluation
Document Issued On: January 10, 1997
Note: While this guidance document represents a final document, comments and suggestions may be
submitted at any time for Agency consideration by contact
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